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ZOLINZA

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Zolinza Adverse Events Reported to the FDA Over Time

How are Zolinza adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Zolinza, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Zolinza is flagged as the suspect drug causing the adverse event.

Most Common Zolinza Adverse Events Reported to the FDA

What are the most common Zolinza adverse events reported to the FDA?

Nausea
55 (3.07%)
Dehydration
50 (2.79%)
Diarrhoea
43 (2.4%)
Fatigue
38 (2.12%)
Death
34 (1.9%)
Weight Decreased
34 (1.9%)
Mycosis Fungoides
32 (1.78%)
Vomiting
30 (1.67%)
Anaemia
27 (1.51%)
Pyrexia
27 (1.51%)
Thrombocytopenia
27 (1.51%)
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Decreased Appetite
26 (1.45%)
Anorexia
22 (1.23%)
Platelet Count Decreased
22 (1.23%)
Underdose
21 (1.17%)
Dizziness
20 (1.12%)
Pneumonia
20 (1.12%)
Asthenia
19 (1.06%)
Syncope
18 (1%)
Alanine Aminotransferase Increased
17 (.95%)
Myocardial Infarction
17 (.95%)
Renal Failure
17 (.95%)
Abdominal Pain
16 (.89%)
Deep Vein Thrombosis
14 (.78%)
Dysgeusia
14 (.78%)
Malaise
14 (.78%)
Respiratory Failure
14 (.78%)
Blood Creatinine Increased
13 (.73%)
Constipation
13 (.73%)
Disease Progression
13 (.73%)
Drug Ineffective
13 (.73%)
Febrile Neutropenia
13 (.73%)
White Blood Cell Count Decreased
13 (.73%)
Aspartate Aminotransferase Increase...
12 (.67%)
Sepsis
12 (.67%)
Dyspnoea
11 (.61%)
Neutropenia
11 (.61%)
Pneumonitis
11 (.61%)
Haemoglobin Decreased
10 (.56%)
Hyponatraemia
10 (.56%)
Mucosal Inflammation
10 (.56%)
Off Label Use
10 (.56%)
Pulmonary Embolism
10 (.56%)
Adverse Event
9 (.5%)
Blindness Unilateral
9 (.5%)
Cardiac Failure
9 (.5%)
General Physical Health Deteriorati...
9 (.5%)
Headache
9 (.5%)
Mass
9 (.5%)
Pleural Effusion
9 (.5%)
Rash
9 (.5%)
Renal Disorder
9 (.5%)
Renal Failure Acute
9 (.5%)
Vitreous Haemorrhage
9 (.5%)
Cardiac Failure Congestive
8 (.45%)
Hypercalcaemia
8 (.45%)
Hypokalaemia
8 (.45%)
Alopecia
7 (.39%)
Back Pain
7 (.39%)
Blood Bilirubin Increased
7 (.39%)
Chills
7 (.39%)
Dry Mouth
7 (.39%)
Hypocalcaemia
7 (.39%)
Hypotension
7 (.39%)
Oedema Peripheral
7 (.39%)
Pancytopenia
7 (.39%)
Acute Prerenal Failure
6 (.33%)
Acute Pulmonary Oedema
6 (.33%)
Aphagia
6 (.33%)
Blood Alkaline Phosphatase Increase...
6 (.33%)
Cellulitis
6 (.33%)
Drug Interaction
6 (.33%)
Drug Level Increased
6 (.33%)
Malnutrition
6 (.33%)
Muscle Spasms
6 (.33%)
Pain
6 (.33%)
Pruritus
6 (.33%)
T-cell Lymphoma
6 (.33%)
Visual Impairment
6 (.33%)
Blood Pressure Decreased
5 (.28%)
Cardio-respiratory Arrest
5 (.28%)
Condition Aggravated
5 (.28%)
Cough
5 (.28%)
Hypermagnesaemia
5 (.28%)
Hypovolaemic Shock
5 (.28%)
Infection
5 (.28%)
Injection Site Reaction
5 (.28%)
Intentional Drug Misuse
5 (.28%)
Intra-abdominal Haemorrhage
5 (.28%)
Malignant Melanoma
5 (.28%)
Pneumothorax
5 (.28%)
Small Intestinal Obstruction
5 (.28%)
Staphylococcal Infection
5 (.28%)
Supraventricular Tachycardia
5 (.28%)
Transient Ischaemic Attack
5 (.28%)
Tumour Lysis Syndrome
5 (.28%)
White Blood Cell Count Increased
5 (.28%)
Abdominal Pain Lower
4 (.22%)
Acute Myeloid Leukaemia
4 (.22%)
Adverse Drug Reaction
4 (.22%)
Arrhythmia
4 (.22%)

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This graph shows the top adverse events submitted to the FDA for Zolinza, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Zolinza is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Zolinza

What are the most common Zolinza adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Zolinza, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Zolinza is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Zolinza According to Those Reporting Adverse Events

Why are people taking Zolinza, according to those reporting adverse events to the FDA?

Mycosis Fungoides
150
T-cell Lymphoma
27
Multiple Myeloma
13
Acute Myeloid Leukaemia
12
Breast Cancer Metastatic
7
Metastases To Central Nervous Syste...
7
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Myelodysplastic Syndrome
7
Eosinophilia
6
Lung Neoplasm Malignant
6
Non-small Cell Lung Cancer
5
Glioblastoma Multiforme
4
Lymphoma
4
Mycosis Fungoides Stage Ii
4
Non-hodgkins Lymphoma
4
Product Used For Unknown Indication
3
Brain Stem Glioma
3
Mycosis Fungoides Refractory
3
Breast Cancer
2
Peripheral T-cell Lymphoma Unspecif...
2
Neoplasm
2
Gastric Cancer
2
Ovarian Epithelial Cancer Recurrent
2
Sarcoma
2
Brain Neoplasm
2
T-cell Lymphoma Stage Iv
1
Acute Leukaemia
1
Brain Neoplasm Malignant
1
Neoplasm Malignant
1
Central Nervous System Neoplasm
1
Chromosome Analysis Abnormal
1
Rectal Cancer
1
Testis Cancer
1
Anaplastic Large Cell Lymphoma T- A...
1
Thrombocytopenia
1
B-cell Lymphoma
1
T-cell Type Acute Leukaemia
1
Mantle Cell Lymphoma
1

Drug Labels

LabelLabelerEffective
ZolinzaMerck Sharp & Dohme Corp.14-NOV-11
ZolinzaMerck Sharp & Dohme Corp.24-APR-13

Zolinza Case Reports

What Zolinza safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Zolinza. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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